1. Field of the Invention
The present invention relates to a composition, and more particularly to the composition for reducing localized fat or promoting weight loss. The present invention also relates to a method of said composition, and more particularly to the method for reducing localized fat or promoting weight loss. The present invention also relates to a pharmaceutical composition, and more particularly to the pharmaceutical composition for reducing localized fat or promoting weight loss. The present invention also relates to a method of using the pharmaceutical composition, and more particularly to a method of using the pharmaceutical composition for reducing localized fat or promoting weight loss.
2. Description of the Prior Arts
With increasing awareness level in beauty as well as self-health, body shape and weight control, weight loss and body fitness are no longer issues cared only by obese individuals. In view of that, weight loss and fitness center and weight management market are booming, driving the development of diet foods, fitness products, weight loss clinical management, medical equipment, fitness equipment, and so on. According to the report “Global Weight Loss and Gain Market 2009-2014” by Markets, the global weight-management market was expected to be US $586.3 billion in 2014 and $650.9 billion in 2015; wherein the main market scale of United States was expected to reach $310 billion, and the market scale of Europe, $238 billion. The rise of consumer health consciousness especially on the chronic diseases caused by obesity made it was noticed globally. Meanwhile, not only obesity population but also numbers of healthy individual were focused on body weight control and body contouring result in prosperity and continuing growth of body contouring market. The statistics of American Society of Plastic Surgeons (ASPS) showed that demand of body contouring was ranked first in the orthopedic field and will be kept annual growing rate at about 12.3% until 2017. “Global Pipeline Analysis, Competitive Landscape and Market Forecasts” published by Research and Markets showed that global market of body contouring equipment reached $900 million in 2010 and would be $2 billion in 2017. The demand of the body contouring market is huge and keeping growing accompanied by variety of liposuction and lipolysis as well as the high risk and unsafe medical treatments.
Conventional liposuction surgery was developed as early as in the 1970s that the subbasal nerves and blood vessels were damaged greatly because of dry liposuction under negative pressure without any infusion buffer and concomitant with high risk of surgery due to substantial blood loss. Tumescent liposuction and superwet liposuction were developed later wherein tumescent liposuction anesthetic and vasoconstrictor were added in infusion solution while in superwet liposuction equal volume of infusion solution was supplied to replace the removed fat mass. In Tumescent liposuction, even though local anesthesia replaces intravenous anesthesia, large amount of anesthetic requires at least 12 hours to turnover and hence the risks were increased. Superwet liposuction has been adopted recently, which is characterized by equal volume exchange of infusion solution and extracted fat to reduce the chance of overload infusion. However, liposuction sites are limited to abdomen, thighs and other areas with large fat accumulation, and the efficacy and safety of liposuction depend entirely on the skilled operator. Liposuction is a harmful and time-consuming process to body which causes severe postoperative bruising, swelling, pain and sensory paralysis, scar tissue, unsmooth skin surface, and other side effects. In addition, operation time of liposuction is longer as well as increased the blood loss, surgery risk, and the four to six weeks recovery period. Although auxiliary liposuction instrument such as ultrasound and laser are developed, the key factor is still the doctor's skill. Furthermore, tissue burn and poor efficacy are common while using auxiliary liposuction equipment. In view of the drawback in liposuction, the aesthetic medical industry of United States and Europe are focusing on the development of medical equipment since the 1980s. The trend of medical cosmetic equipment for liposuction is minimally invasive and even non-invasive lipolysis. The objects of lipolytic product or equipment are reduced blood loss, shortened recovery period, less invasion, high safety, convenience, and smaller wound accompanied by the advantages of better efficacy and competitive price for aesthetic medical market.
Mesotherapy is a lipolytic method using phosphatidylcholine or sodium deoxycholate as active ingredient to lyse the injected adipose tissues. The structure of phosphatidylcholine and sodium deoxycholate is similar to the component of cell membrane molecules therefore break down the cell membrane of adipocytes and trigger cell necrosis. However, the effect of phosphatidylcholine and sodium deoxycholate is not only specific to adipocytes but also to other surrounding cells which causes a series of inflammation reaction around the injection site with severe pain and swelling and even local tissue necrosis or infection. Although lipolysis injection overcomes the site limitation of using liposuction, one lipolysis injection treatment course may require dozens of injections every 2 weeks for 3 to 6 cycles to reach the goal of body contouring. Even the addition of anesthetic in the lipolysis injection, the injected site may still suffer from severe inflammation and pain after anesthesia withdrawn, longer treatment period and injection dosages are also concerned. Consider of the risks of severe postoperative pain, nerve paralysis, local tissue necrosis or infections, the allowed single injection volume is very limited, only restricted on the application of submental fat, and other potential side effects, most aesthetic medical surgeons are unwilling to use the formulation described for localized fat reduction even that is the first lipolytic formulation approved for sale in the United States.
Overall, more effective, limited side effects, safer, and more application sites products for reducing localized adipose are eager to be launched to fit the demand of the surgeons and consumers as well as the trend of aesthetic medical marker.